FDA.reportPublic FDA data

PREMIER DENTAL PRODUCTS CO.

Matched from indexed company URL: PREMIER DENTAL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
25115562511556PREMIER DENTAL PRODUCTS CO.1Y2026-01-011710 Romano Dr PLYMOUTH MEETING PA US 19462
30165489653016548965PREMIER DENTAL LAB LLC1Y2020-04-25310 N County line Rd Hinsdale IL US 60521

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
75931514387613K972138CARR RIGID CONTAINER SYSTEMFRG1997-11-13
75931300463042K970992PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUSGEH1997-06-17
75931703114397K945492HIGH TEMPERATURE CAUTERYGEI1995-01-30
75931446317133K933766HIGH-Q-BONDEBF1994-01-26
75931097171290K932827ALPHA-DENT CORE BUILDUP PASTEEBF1993-09-23
75931229405150K924823MICRODOSE SILANEELL1993-03-16
75931387112178K923332ELECTROSURGICAL ELECTRODESGEI1992-10-13
75931635195127K896303BIOPSY PUNCHLRY1990-02-13
75931644400585K884015PREMIER DECANNULATION STOPPERBTO1988-11-03
75931872417994K260682Bond-PR™ Universal AdhesiveKLE2026-03-03
75931543755900K253513MultiMatch Flow Chameleon AntiMicrobial CompositeEBF2025-11-07
75932070837987K223632Premier's MultiMatch Universal Chameleon Restorative CompositeEBF2022-12-06
75932060168810K180682AeroPro Cordless Prophy SystemEKX2019-02-27
75931749956977K161580Premier SealantEBC2016-10-18
75931824030087K153334Oral-B 5% Sodium Fluoride VarnishLBH2016-05-20
75932034927613K151123Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier FilmPEM2016-03-03
75932019421233K150601Zeramic Adhesive Resin CementEMA2015-07-22
75931509703727K141839PREMIER ETCHKLE2014-11-17
75931083551376K132526KNIT-PAK+MVL2013-11-26
75931699659673K131212PREMIER CERAMIC PRIMERKLE2013-08-26
75931666156176K102006CRYOMEGAGEH2010-10-06
75931720302758K083695TRAXODENTMVL2009-04-28
75931934676765K062683ENAMEL PRO VARNISHLBH2006-11-21
75931744626959K062166ENAMEL PROEJR2006-11-21
75932070450598K061998PREMIER SELF-ETCHING BOND ENHANCERKLE2006-10-04
75931709349471K051866PREMIER TEMPORARY CEMENTEMA2005-09-06
75931670365480K040098VARNISHAMERICALBH2004-02-04
75931370507764K033309PREMIER IMPLANT CEMENT, MODEL 3001450EMA2004-01-26
75931682715975K031463MARINA MEDICAL SILICONE PESSARYHHW2003-11-18
75931870301256K012160COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408EBF2001-09-27
75931841044449K010195PREMIER ULTRASONIC SCALER AND INSERTSELC2001-04-17
75931083548239K002042TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018HGI2001-02-01
75931155477676
75931259901368
75931260994469
75931318921301
75931665343614
75931889551327
75931011221493
75931029944973
75931044878993
75931058923024
75931091600799
75931096660348
75931102967814
75931109374664
75931109502699
75931132743499
75931134279633
75931176802471
75931179172608
75931199627495
75931201998550
75931218168993
75931258051775
75931258582127
75931266365291
75931271170737
75931278945846
75931281229068
75931290332459
75931292866517
75931293438411
75931320135808
75931321232558
75931333374678
75931336384091
75931338611984
75931346237435
75931380122736
75931383348917
75931392391414
75931434244831
75931438505199
75931448412447
75931485083347
75931503557287
75931505563183
75931508768526
75931522469057
75931547983930
75931558010900
75931580583955
75931597670080
75931607574945
75931610649947
75931616222631
75931617717692
75931620168757
75931644472538
75931647483626
75931668251452
75931671962303
75931673315289
75931699694956
75931719296185
75931733554538
75931750146443
75931760232191
75931773504970
75931778744733
75931786403144
75931797110600
75931827739540
75931835836485
75931857272739
75931869895850
75931899323809
75931902817972
75931919504109
75931929245185
75931952143045
75931962709545
75931976791632
75932003097016
75932013091134
75932041652246
75932041868722
75932044448582

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EBF52025-11-07
KLE42026-03-03
LBH32016-05-20
EMA32015-07-22
MVL22013-11-26
GEH22010-10-06
GEI21995-01-30
EKX12019-02-27
EBC12016-10-18
PEM12016-03-03
EJR12006-11-21
HHW12003-11-18
ELC12001-04-17
HGI12001-02-01
FRG11997-11-13
ELL11993-03-16
LRY11990-02-13
BTO11988-11-03

NDC#

Enamelon

Premier Dental Products Company

stannous fluoride

PMN#

KNIT-PAK+

2013-11-26

PREMIER DENTAL PRODUCTS CO.

TRAXODENT

2009-04-28

PREMIER DENTAL PRODUCTS CO.

REPRODENT

1979-03-02

PREMIER DENTAL PRODUCTS CO.

45 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next